WellSky Blood Centers

GUDID B105BLOODCENTERS2018

Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols

WELLSKY CORPORATION

Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software Blood bank information system application software

• Primary Device ID: B105BLOODCENTERS2018
• NIH Device Record Key: 800fe847-e799-490c-a4d3-76fbe026b801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WellSky Blood Centers
• Version Model Number: 2018
• Company DUNS: 177240249
• Company Name: WELLSKY CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B105BLOODCENTERS2018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK180200

FDA Product Code

• MMH: Blood Establishment Computer Software And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [WellSky Blood Centers]

• B105BLOODCENTERS2019: Blood Centers is a comprehensive, modular, computerized system intended to be used by trained p
• B105BLOODCENTERS0: Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe
• B105BLOODCENTERS2023: Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe
• B105BLOODCENTERS2018: Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe